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Study Evaluating The Effects Of Neratinib After Adjuvant Trastuzumab In Women With Early Stage Breast Cancer (ExteNET)

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ClinicalTrials.gov Identifier: NCT00878709
Recruitment Status : Completed
First Posted : April 9, 2009
Results First Posted : October 9, 2017
Last Update Posted : June 11, 2021
Sponsor:
Information provided by (Responsible Party):
Puma Biotechnology, Inc.

Study Description
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Brief Summary:
The purpose of this study is to investigate whether neratinib can further reduce the risk of recurrence from previously diagnosed HER-2 positive breast cancer after adjuvant treatment with trastuzumab.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: neratinib Other: placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2840 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial Of Neratinib (HKI-272) After Trastuzumab In Women With Early-Stage HER-2/Neu Overexpressed/Amplified Breast Cancer
Actual Study Start Date : July 9, 2009
Actual Primary Completion Date : August 21, 2014
Actual Study Completion Date : October 4, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Neratinib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Neratinib
240 mg orally daily for one year
 Drug: neratinib
Other Names:
  • HKI-272
  • Nerlynx
Placebo Comparator: Placebo
orally daily for one year
 Other: placebo


Outcome Measures
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Primary Outcome Measures :
  1. Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 [ Time Frame: From randomization until time of event up to 2 years ]
    Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.

  2. Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Randomization until death due to any cause (up to 119 Months) ]
    OS was defined as the time from randomization to death due to any cause, censored at the last date known alive.

  2. Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 2 [ Time Frame: From randomization until time of event up to 2 years ]
    Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.

  3. Kaplan-Meier Estimates of Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]
  4. Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 2 [ Time Frame: From randomization until time of event up to 2 years ]
    Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.

  5. Kaplan-Meier Estimates of Distant Disease-free Survival (DDFS) at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]
  6. Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 2 [ Time Frame: From randomization until time of event up to 2 years ]
    Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.

  7. Kaplan-Meier Estimates of Time to Distant Recurrence (TTDR) Survival at Year 2 by Treatment Arms [ Time Frame: From randomization until time of event up to 2 years ]
  8. Central Nervous System Recurrence in Neratinib Arm Compared to Placebo Arm at Year 2 [ Time Frame: From randomization until time of event up to 2 years ]
    CNS recurrence is defined as the time from randomization to CNS as the first distant recurrence. Competing events include distant recurrence at other sites as the first distant recurrence and death from any cause prior to distant recurrence.

  9. Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 2 [ Time Frame: From randomization until time of event up to 2 years ]
    Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).


Other Outcome Measures:
  1. Invasive Disease-free Survival (iDFS) in Neratinib Arm Compared to Placebo Arm at Year 5 [ Time Frame: From randomization until time of event up to 5 years ]
    Invasive disease-free survival time is defined as the time from date of randomization until the first disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.

  2. Kaplan-Meier Estimates of Invasive Disease-free Survival (iDFS) at Year 5 by Treatment Arms [ Time Frame: From randomization until time of event up to 5 years ]
  3. Disease-free Survival Including Ductal Carcinoma in Situ (DFS-DCIS) in Neratinib Arm Compared to Placebo Arm at Year 5 [ Time Frame: From randomization until time of event up to 5 years ]
    Disease-free survival including DCIS time is defined as the time from date of randomization until the first occurrence of DCIS or an iDFS event (an iDFS event including invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, or distant recurrence and death from any.

  4. Distant Disease-free Survival (DDFS) in Neratinib Arm Compared to Placebo Arm at Year 5 [ Time Frame: From randomization until time of event up to 5 years ]
    Distant disease-free survival time is defined as the time from date of randomization until the first occurrence of distant recurrence or death from any cause.

  5. Percentage of Participants With Time to Distant Recurrence (TTDR) Event in Neratinib Arm Compared to Placebo Arm at Year 5 [ Time Frame: From randomization until time of event up to 5 years ]
    Percentage of Participants with TTDR events is reported. TTDR is defined as the time from date of randomization until the first occurrence of distant recurrence or death from breast cancer.

  6. Cumulative Incidence of Central Nervous System Recurrence (CNS) at Year 5 [ Time Frame: From randomization until time of event up to 5 years ]
    Cumulative incidence of Central Nervous System Recurrence (CNS) is estimated by Gray's method (Gray,1988).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage II through IIIC HER-2/erbB-2 positive breast cancer with node positive disease.
  • Been treated for early breast cancer with standard of care duration of trastuzumab.
  • Could have been treated neoadjuvantly but have not reached pathologic complete response.

Exclusion Criteria:

  • Positive clinical and radiologic assessments for local or regional recurrence of disease at the time of study entry.
  • History of heart disease.
  • Corrected QT (QTc) interval >0.45 seconds
  • History of gastrointestinal disease with diarrhea as the major symptom.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00878709


Locations
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Sponsors and Collaborators
Puma Biotechnology, Inc.
Investigators
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Study Director: Senior Vice President Clinical Science and Pharmacology Puma Biotechnology, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Puma Biotechnology, Inc.
ClinicalTrials.gov Identifier: NCT00878709    
Other Study ID Numbers: 3144A2-3004 / B1891004
First Posted: April 9, 2009    Key Record Dates
Results First Posted: October 9, 2017
Last Update Posted: June 11, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Puma Biotechnology is committed to sharing clinical trial data and information to help physicians and patients make informed treatment decisions, and to help qualified researchers advance scientific knowledge.

In accordance with legal and regulatory requirements, Puma publishes study protocol information and clinical study results on clinical trial registries, including ClinicalTrials.gov and EU Clinical Trials Register. Puma also publishes information about clinical studies in peer-reviewed scientific journals and shares data in scientific meetings.

Puma commits to safeguarding confidentiality and patient privacy throughout the clinical trial data and information sharing process. Any patient-level data will be anonymized to protect personally identifiable information.

Qualified researchers and study participants may submit requests for other study documentation and clinical trial data to clinicaltrials@pumabiotechnology.com for consideration.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Clinical study documents and clinical trial data may be requested by qualified researchers and study participants for studies that have been completed for at least 18 months, and for which the indication of the drug has been approved in the US and/or EU, as applicable. Requests will be accepted for up to 24 months after the criteria described in this section are met.
Access Criteria:

Requestors must provide organizational contact information; a detailed research plan, including outcomes; timeline for completion of the research; qualifications of the research team; funding source; and potential conflicts of interest.

Puma will not provide access to patient-level data if there is a reasonable likelihood that individual patients could be identified, or in cases where confidentiality or consent provisions prohibit transfer of data or information to third parties. Additionally, Puma will not disclose information that jeopardizes intellectual property rights or divulges confidential commercial information.
URL: https://pumabiotechnology.com/data_sharing_policy.html

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Puma Biotechnology, Inc.:
HER-2/erbB-2 positive breast cancer
breast cancer
adjuvant therapy
neratinib
 HKI-272
Nerlynx
PB-272
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases